Back to resultsTo Study The Incidence And Outcome Of Paracentesis Induced Circulatory Dysfunction in Decompensated Cirrhotics Undergoing Less Than 5 Litres Of Ascitic Fluid Tap With Or Without Albumin Infusion.
Primary Purpose
Decompensated Cirrhosis
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Albumin
ascitic fluid
Sponsored by
About this trial
This is an interventional treatment trial for Decompensated Cirrhosis
Eligibility Criteria
Inclusion Criteria:
- All Cirrhotics decompensated with ascites admitted in the hospital.
- Grade II/III ascites
- Need for paracentesis.
Exclusion Criteria:
- Age <12 or > 75 years
- Hepatocellular carcinoma
- Non cirrhotic ascites such as malignancy or tubercular peritonitis
- Serum Cr >1.5mg%
- Refractory septic shock
- Grade III/IV hepatic encephalopathy
- Abdominal wall cellulitis
- Active variceal bleed
- Respiratory, cardiac and renal failure
- Refusal to participate in the study
Sites / Locations
- Institute of Liver and Biliary Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Albumin
No Albumin
Arm Description
MVP (Moderate Volume Paracentesis) of less than 5 liters with iv albumin at a dose 8 gms/l of ascitic fluid.
MVP(Moderate Volume Paracentesis) of less than 5 liters without albumin.
Outcomes
Primary Outcome Measures
Incidence of PICD (Paracentesis Induced Circulatory Dysfunction).
Secondary Outcome Measures
Survival
Total number of patients develop Hepatorenal Syndrome.
Total number of patients develop hyponatremia.
Changes in plasma Renin activity.
Changes in aldosterone with volume of ascitic fluid tap.
Full Information
NCT ID
NCT02467322
First Posted
June 4, 2015
Last Updated
June 9, 2017
Sponsor
Institute of Liver and Biliary Sciences, India
1. Study Identification
Unique Protocol Identification Number
NCT02467322
Brief Title
To Study The Incidence And Outcome Of Paracentesis Induced Circulatory Dysfunction in Decompensated Cirrhotics Undergoing Less Than 5 Litres Of Ascitic Fluid Tap With Or Without Albumin Infusion.
Official Title
To Study The Incidence And Outcome Of Paracentesis Induced Circulatory Dysfunction In Decompensated Cirrhotics Undergoing Less Than 5 Litres Of Ascitic Fluid Tap With Or Without Albumin Infusion
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
February 23, 2015 (Actual)
Primary Completion Date
December 15, 2016 (Actual)
Study Completion Date
December 15, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Liver and Biliary Sciences, India
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
All consecutive patients admitted in ILBS from MAY 2015 to DECEMBER 2016. Decompensated cirrhosis patients will be randomized into Group 1: MVP (Moderate Volume Paracentesis) of less than 5 litres with iv albumin at a dose 8 gms/l of ascitic fluid Group 1: MVP (Moderate Volume Paracentesis) of less than 5 litres without albumin .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Decompensated Cirrhosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Albumin
Arm Type
Experimental
Arm Description
MVP (Moderate Volume Paracentesis) of less than 5 liters with iv albumin at a dose 8 gms/l of ascitic fluid.
Arm Title
No Albumin
Arm Type
Active Comparator
Arm Description
MVP(Moderate Volume Paracentesis) of less than 5 liters without albumin.
Intervention Type
Drug
Intervention Name(s)
Albumin
Intervention Description
MVP of less than 5 liters with iv albumin at a dose 8 gms/L of ascitic fluid.
Intervention Type
Drug
Intervention Name(s)
ascitic fluid
Primary Outcome Measure Information:
Title
Incidence of PICD (Paracentesis Induced Circulatory Dysfunction).
Time Frame
1 Year
Secondary Outcome Measure Information:
Title
Survival
Time Frame
28 days
Title
Total number of patients develop Hepatorenal Syndrome.
Time Frame
1 Year
Title
Total number of patients develop hyponatremia.
Time Frame
1 Year
Title
Changes in plasma Renin activity.
Time Frame
1 Year
Title
Changes in aldosterone with volume of ascitic fluid tap.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All Cirrhotics decompensated with ascites admitted in the hospital.
Grade II/III ascites
Need for paracentesis.
Exclusion Criteria:
Age <12 or > 75 years
Hepatocellular carcinoma
Non cirrhotic ascites such as malignancy or tubercular peritonitis
Serum Cr >1.5mg%
Refractory septic shock
Grade III/IV hepatic encephalopathy
Abdominal wall cellulitis
Active variceal bleed
Respiratory, cardiac and renal failure
Refusal to participate in the study
Facility Information:
Facility Name
Institute of Liver and Biliary Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110070
Country
India
12. IPD Sharing Statement
Learn more about this trial
To Study The Incidence And Outcome Of Paracentesis Induced Circulatory Dysfunction in Decompensated Cirrhotics Undergoing Less Than 5 Litres Of Ascitic Fluid Tap With Or Without Albumin Infusion.
We'll reach out to this number within 24 hrs